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Evidence review for assessing pelvic organ prolapse

Urinary incontinence and pelvic organ prolapse in women: management

Evidence review G

NICE Guideline, No. 123

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3319-8

Assessing pelvic organ prolapse

Review question

What is the most effective strategy for assessing pelvic organ prolapse (POP)?

Introduction

The initial diagnosis of prolapse often occurs when a woman presents to her general practitioner (GP) with symptoms (such as a lump or bulge, or of a dragging sensation in the vagina, or with incontinence) and with visual identification on examination. However, prolapse can also be asymptomatic and be discovered incidentally, for example, during a smear test.

The objective of this review is to determine the most effective strategy for assessing POP to inform appropriate management options. This review aims to examine details that should be recorded about patient symptoms as well as to set basic standards of assessment for any healthcare provider (generalist or specialist).

Summary of the protocol

See Table 1 for a summary of the Population, Index test, Reference standard and Outcome (PIRO) characteristics of this review.

Table 1. Summary of protocol (PIRO table).

Table 1

Summary of protocol (PIRO table).

For further details see the full review protocol in appendix A.

Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual 2014. Methods specific to this review question are described in the review protocol in appendix A and for a full description of the methods see supplementary document C.

Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).

Clinical evidence

Included studies

Five studies were included in the review (Kelvin 1999; Kim 2014; Lone 2014; Reimers 2017; Tan 2005).

  • Kelvin 1999 and Kim 2014 compared the diagnostic accuracy of dynamic cystoproctography or dynamic colpocystoproctography, respectively, with data previously acquired on physical examination in women with pelvic floor dysfunction. Kim 2014 specifically assessed women with urinary incontinence (UI) and POP planned for combined surgery.
  • Lone 2014 was a non-randomised controlled trial comparing the diagnostic accuracy of pre-operative pelvic floor ultrasound with clinical assessment.
  • Reimers 2017 assessed the diagnostic accuracy between self-reported ICIQ-VS and clinical assessment for vaginal bulge.
  • Tan 2005 compared the diagnostic accuracy of a standardised questionnaire and physical examination (POP_Q examination).

For a summary of included studies see Table 2.

See also the literature search strategy in appendix B, study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E, and GRADE tables (modified for diagnostic evidence) in appendix F.

Excluded studies

Studies excluded from this review and reasons for their exclusions are provided in appendix K.

Summary of clinical studies included in the evidence review

Table 2 provides a brief summary of the included studies.

Table 2. Summary of included studies.

Table 2

Summary of included studies.

Also see clinical evidence tables in appendix D.

Quality assessment of clinical studies included in the evidence review

The GRADE quality assessment, modified for diagnostic reviews, was conducted. The full clinical evidence profiles for this review are presented in appendix F.

Economic evidence

Included studies

A systematic review of the economic literature was conducted but no studies were found which were applicable to this review question. See supplementary document D for further information.

Excluded studies

No studies were found which were applicable to this review question,

Summary of studies included in the economic evidence review

No economic evaluations were found which were applicable to this review question.

Economic model

No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.

Evidence statements

Sensitivity and specificity
Dynamic cystoproctography versus physical examination (Baden Walker technique)

Very low quality evidence from 1 observational study (N = 170) showed that the overall sensitivity and specificity for dynamic cystoproctography compared to Baden Walker was 94% (89 to 98) and 18% (8 to 33) to detect rectocele in adult women.

  • Very low quality evidence from 1 observational study (N = 170) showed that the overall sensitivity and specificity for dynamic cystoproctography compared to Baden-Walker was 35% (24 to 48) and 77% (68 to 85) to detect enterocele in adult women.
  • Very low quality evidence from 1 observational study (N = 170) showed that the overall sensitivity and specificity for dynamic cystoproctography compared to Baden-Walker was 96% (92 to 99)and 18% (7 to 35) to detect cystocele in adult women.
Dynamic colpocystoproctography versus physical examination (POP-Q)
  • Very low quality evidence from 1 observational study (N = 109) showed that the overall sensitivity and specificity for dynamic cystoproctography compared to POP-Q was 100% (93 to 100) and 46% (33 to 59) to detect rectocele in adult women.
  • Very low quality evidence from 1 observational study (N = 109) showed that the overall specificity for dynamic colpocystoproctography compared to POP-Q was 98% (94 to 100) to detect enterocele in adult women. Sensitivity for this test against POP-Q was not estimable.
  • Very low quality evidence from 1 observational study (N = 109) showed that the overall sensitivity and specificity for dynamic cystoproctography compared to POP-Q was 100% (95 to 100) and 67% (47 to 83) to detect cystocele in adult women.
2D transperineal ultrasound versus physical examination (POP-Q)
  • Very low quality evidence from 1 observational study (N = 145) showed that the overall sensitivity and specificity for 2D transperineal ultrasound compared to POP-Q was 39% (28 to 52) and 96% (89 to 99) to detect rectocele in adult women.
  • Very low quality evidence from 1 observational study (N = 153) showed that the overall sensitivity and specificity for 2D transperineal ultrasound compared to POP-Q was 59% (46 to 71) and 100% (96 to 100) to detect cystocele in adult women.
  • Very low quality evidence from 1 observational study (N = 140) showed that the overall sensitivity and specificity for 2D transperineal ultrasound compared to POP-Q was 69% (53 to 82) and 95% (88 to 98) to detect cervix/vault prolapse in adult women.
Self-reported vaginal bulge versus physical examination (POP-Q)
  • Very low quality evidence from 1 observational study (N=300) showed that the overall sensitivity and specificity for self-reported vaginal bulge (as measured by the ICIQ-VS) compared to POP-Q to detect anatomical changes during pregnancy at 21 weeks gestation was 31% (9 to 61) and 85% (80 to 89) and at 37 gestational weeks [N=270] was 50% (1 to 99) and 83% (78 to 87) in women having their first child.
  • Very low quality evidence from 1 observational study (N=280) showed that the overall sensitivity and specificity for self-reported vaginal bulge (as measured by the ICIQ-VS) compared to POP-Q to detect anatomical changes during pregnancy was 52% (31 to 72) and 83% (78 to 87) at 6 weeks after childbirth, 20% (1 to 72) and 77% (70 to 83) 6 months after childbirth (N=195), and 0% (0 to 60) and 81% (74 to 86) at 12 months after childbirth (N=176), in women having their first child.
  • Very low quality evidence from 1 observational study (N = 1912) showed that the overall sensitivity and specificity for self-reported vaginal bulge compared to POP-Q, was 67% (63 to 70) and 87% (85 to 89) to detect signs of prolapse in adult women.
Self-reported urinary splinting versus physical examination (POP-Q)
  • Very low quality evidence from 1 observational study (N = 1912) showed that the overall sensitivity and specificity for self-reported urinary splinting compared to POP-Q was 18% (15 to 21) and 97% (96 to 98) to detect signs of prolapse in adult women.
Self-reported digital assistance versus physical examination (POP-Q)
  • Very low quality evidence from 1 observational study (N = 1939) showed that the overall sensitivity and specificity for self-reported digital assistance compared to POP-Q was 32% (27 to 37) and 87% (86 to 89) to detect signs of prolapse in adult women.

Economic evidence statements

No studies were found which were applicable to this review question.

The committee’s discussion of the evidence

Interpreting the evidence
The outcomes that matter most

The committee considered sensitivity and specificity to be critical outcomes because they are the preferred method for assessing the accuracy of diagnostic tests and because they wanted to minimise the false positive and false negative rates. Women incorrectly receiving a diagnosis of pelvic organ prolapse would receive unnecessary further tests or treatments and women who were incorrectly classified as not having pelvic organ prolapse may be falsely reassured and would not get the treatment that they need. The committee also considered positive and negative likelihood ratios to be critical outcomes. The committee considered patient satisfaction, symptom improvement (self-reported and assessed using validated questionnaires), change in management option, and pain or anxiety associated with test/assessment. Evidence on patient satisfaction and pain or anxiety associated with test/assessment was not found from the literature search.

The quality of the evidence

The risk of bias of individual studies was assessed using the QUADAS-2 checklist, and the quality of the evidence for each index test was assessed by adapting the GRADE approach to a systematic review of diagnostic test accuracy. The quality of the evidence for all comparisons was very low, meaning there is limited confidence in the results presented. The evidence comparing dynamic cystoproctography with Baden Walker and self-reported vaginal bulge with POP-Q was downgraded because it was indirect and included small sample sizes; more than half the women included in Kelvin (1999) had undergone previous hysterectomy or other reconstructive pelvic floor surgery (i.e. they were not undergoing initial investigation of POP); women included in Kim (2014) were planned for combined surgery for confirmed POP and UI; it was unclear whether women enrolled in Reimers (2017) were consecutive or a random sample. In addition, the evidence was downgraded because of a significant risk of bias, including a lack of blinding to the interpretation of index test and/or reference standard results; an unclear interval between index test and reference standard; and exclusion of women from the analyses.

Benefits and harms

The committee discussed the evidence that self-reported symptoms showed high specificity in detecting signs of prolapse, but also noted that prolapse was frequently an incidental finding. They agreed that the evidence presented did not show the benefit of relying only on self-reported symptoms or imaging techniques in the routine assessment of women with suspected pelvic organ prolapse.

Based on their expertise and by consensus, they emphasised the importance of the GP taking a clear history and carrying out a careful examination to inform the initial discussion and to rule out other differential diagnoses, before referring for specialist assessment if appropriate.

Based on their experience, the committee emphasised that vaginal prolapse can be diagnosed incidentally during examination in secondary care. The committee decided that in this situation it was important that women are referred to a clinician with a special interest in prolapse for an assessment and management plan.

Evidence indicated that none of the index tests reached the diagnostic accuracy of the POP-Q reference standard. Based on this and consensus, the committee decided that the POP-Q should be the tool of choice when assessing women suspected of having pelvic organ prolapse. This tool created by the International Continence Society can provide a reliable and reproducible measure of pelvic organ prolapse. Although this instrument is generally thought to be the reference standard, it is possible that not all clinicians use it in practice. As a validated instrument, the POP-Q can provide an objective and standard measure of pelvic organ prolapse during the physical examination, enabling continuity of care if women are referred to a different healthcare setting or healthcare provider. Based on their experience and expertise, the committee also agreed that in specialist settings, it is important to assess the integrity of a woman’s pelvic floor muscles and the presence of vaginal atrophy, and to rule out the presence of a pelvic mass or any other gynaecological pathology, as these factors need to be considered. The committee agreed that a validated pelvic floor symptom questionnaire could aid assessment.

The committee noted that, compared to the reference standard, the evidence presented did not show any added benefit from using imaging techniques (cystoproctography and 2D ultrasound) for the assessment of pelvic organ prolapse. Based on this and their experience and expertise the committee noted that vaginal prolapse can be diagnosed on physical examination alone and when this occurs women should not be routinely referred for imaging because this would delay management and add unnecessary costs.

The committee was aware that on physical examination the apparent severity of prolapse can change with straining or with a change in position (lying or standing) and noted that assessment should take this into account.

The committee agreed, by consensus, that further investigation should be considered when other pelvic floor symptoms are present such as urinary or faecal incontinence, pain or obstructed defecation. Or when the symptoms are not adequately explained by the findings on physical examination.

Cost effectiveness and resource use

There was no published evidence found on the cost effectiveness of different strategies for assessing pelvic organ prolapse in women.

The committee explained that taking a history to include symptoms of prolapse, urinary, bowel, and sexual function; performing an examination to rule out a pelvic mass, other gynaecology pathology and to document presence of prolapse; and discussing treatment preferences with women is standard care and providing this would not incur significant extra costs for the NHS.

Similarly, the recommendation of a specialist evaluation for women referred to secondary care for an unrelated condition who have incidental symptoms or finding of vaginal prolapse is reinforcing standard practice and providing such assessment would not incur significant extra costs for the NHS.

The committee discussed the time it takes to administer validated pelvic floor symptom questionnaires. For example, a questionnaire such as ICIQVS, EPAQ, PFDI, and PFIQ can take 5-15 minutes to administer. The committee expressed their view that the additional time required to administer such questionnaires is negligible given the extremely complex nature of pelvic floor disorders and the potential health benefits associated with having an appropriate assessment.

The use of the most appropriate assessment tools for individual women and their symptoms is likely to minimise the unnecessary use of such assessment tools and may result in cost savings to the NHS. Examples of such targeted investigation include performing urodynamics before surgery for prolapse only when urinary symptoms are bothersome, proctography only if there are symptoms of obstructed defecation or faecal incontinence, and anorectal manometry and ultrasound only if there is faecal incontinence. Importantly, some of these assessment tools are very invasive and may adversely affect health-related quality of life.

The committee explained that if a strategy improves the assessment of women with POP and leads to quicker and more appropriate treatment, the additional costs of this assessment would probably be outweighed by both the improvements in health outcomes and the possible future cost savings to the NHS, especially as delayed and inappropriate treatment can exacerbate symptoms which may require expensive treatment in secondary care at a later time.

References

  • Kelvin 199

    Kelvin, F. M., Hale, D. S., Maglinte, D. D. T., Patten, B. J., Benson, J. T., Female pelvic organ prolapse: Diagnostic contribution of dynamic cystoproctography and comparison with physical examination, American Journal of Roentgenology, 173, 31–37, 1999 [PubMed: 10397095]
  • Kim 2014

    Kim, J. H., Park, S. J., Yi, B. H., Lee, K. W., Kim, M. E., Kim, Y. H., Diagnostic effectiveness of dynamic colpocystoproctography in women planning for combined surgery with urinary incontinence and pelvic organ prolapse, Gynecologic and Obstetric Investigation, 77, 231–239, 2014 [PubMed: 24732713]
  • Lone 2014

    Lone, F., Sultan, A. H., Stankiewicz, A., Thakar, R., The value of pre-operative multicompartment pelvic floor ultrasonography: a 1-year prospective study, British Journal of Radiology, 87, 20140145, 2014 [PMC free article: PMC4112391] [PubMed: 24959953]
  • Reimers 2017

    Reimers, C., Staer-Jensen, J. E., Siafarikas, F., Bo, K., Engh, M. E., Association between vaginal bulge and anatomical pelvic organ prolapse during pregnancy and postpartum: an observational study, International Urogynecology Journal, 11, 11, 2017 [PubMed: 28698892]
  • Tan 2005

    Tan, J. S., Lukacz, E. S., Menefee, S. A., Powell, C. R., Nager, C. W., Albo, M. E., Luber, K. M., Predictive value of prolapse symptoms: A large database study, International Urogynecology Journal, 16, 203–209, 2005 [PubMed: 15875236]

Appendices

Appendix A. Review protocols

Review protocol for review question: What is the most effective strategy for assessing pelvic organ prolapse?

Table 3. Review protocol for assessing pelvic organ prolapse

Appendix B. Literature search strategies

Literature search strategy for review question: What is the most effective strategy for assessing POP?

Database: Medline & Embase (Multifile)

Last searched on Embase Classic+Embase 1947 to 2017 October 03, Ovid MEDLINE(R) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R) 1946 to Present.

Date of last search: 5th October 2017

Database: Cochrane Library via Wiley Online

Date of last search: 5th October 2017

Appendix C. Clinical evidence study selection

Clinical evidence study selection for review question: What is the most effective strategy for assessing POP?

Figure 1. PRISMA flow chart for review question: What is the most effective strategy for assessing POP?

Appendix D. Clinical evidence tables

Clinical evidence tables for review question: What is the most effective strategy for assessing pelvic organ prolapse?

Table 4. Clinical evidence tables (PDF, 310K)

Appendix F. GRADE tables

Appendix G. Economic evidence study selection

Economic evidence study selection for review question: What is the most effective strategy for assessing POP?

One global search was conducted for this review question. See supplementary material D for further information.

Appendix H. Economic evidence tables

Economic evidence tables for review question: What is the most effective strategy for assessing POP?

No economic studies were found which were applicable to this review question.

Appendix I. Economic evidence profiles

Economic evidence profiles for review question: What is the most effective strategy for assessing POP?

No economic studies were found which were applicable to this review question.

Appendix J. Economic analysis

Economic analysis for review question: What is the most effective strategy for assessing POP?

No economic analysis was conducted for this review question.

Appendix K. Excluded studies

Excluded studies for review question: What is the most effective strategy for assessing POP?

Economic studies

No economic evidence was found for this review question. See supplementary material D for further information.

Appendix L. Research recommendation

Research recommendations for review question: What is the most effective strategy for assessing POP?

No research recommendation was made for this topic.

Final

Evidence reviews

These evidence reviews were developed by the National Guideline Alliance hosted by the Royal College of Obstetricians and Gynaecologists

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2019.
Bookshelf ID: NBK577768PMID: 35138777

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